EN 60601-2-17:2004

SLOVENSKI STANDARD
01-maj-2004
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Medical electrical equipment - Part 2-17: Particular requirements for the safety of
automatically-controlled brachytherapy afterloading equipment (IEC 60601-2-17:2004)
Medizinische elektrische Geräte - Teil 2-17: Besondere Festlegungen für die Sicherheit
ferngesteuerter, automatisch betriebener Afterloading-Geräte für die Brachytherapie (IEC
60601-2-17:2004)
Appareils électromédicaux - Partie 2-17: Règles particulières de sécurité des appareils
projecteurs de brachythérapie avec contrôles automatiques (CEI 60601-2-17:2004)
Ta slovenski standard je istoveten z: EN 60601-2-17:2004
ICS:
11.040.60 Terapevtska oprema Therapy equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD EN 60601-2-17
NORME EUROPÉENNE
EUROPÄISCHE NORM April 2004
ICS 11.040.60; 19.100 Supersedes EN 60601-2-17:1996 + A1:1996

English version
Medical electrical equipment
Part 2-17: Particular requirements for the safety
of automatically-controlled brachytherapy afterloading equipment
(IEC 60601-2-17:2004)
Appareils électromédicaux Medizinische elektrische Geräte
Partie 2-17: Règles particulières Teil 2-17: Besondere Festlegungen
de sécurité des appareils projecteurs für die Sicherheit ferngesteuerter,
de brachythérapie automatisch betriebener
avec contrôles automatiques Afterloading-Geräte für die Brachytherapie
(CEI 60601-2-17:2004) (IEC 60601-2-17:2004)

This European Standard was approved by CENELEC on 2004-03-01. CENELEC members are bound to
comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration.

Up-to-date lists and bibliographical references concerning such national standards may be obtained on
application to the Central Secretariat or to any CENELEC member.

This European Standard exists in three official versions (English, French, German). A version in any other
language made by translation under the responsibility of a CENELEC member into its own language and
notified to the Central Secretariat has the same status as the official versions.

CENELEC members are the national electrotechnical committees of Austria, Belgium, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden,
Switzerland and United Kingdom.

CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung

Central Secretariat: rue de Stassart 35, B - 1050 Brussels

© 2004 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.

Ref. No. EN 60601-2-17:2004 E
Foreword
The text of document 62C/363/FDIS, future edition 2 of IEC 60601-2-17, prepared by SC 62C,
Equipment for radiotherapy, nuclear medicine and radiation dosimetry, of IEC TC 62, Electrical
equipment in medical practice, was submitted to the IEC-CENELEC parallel vote and was approved
by CENELEC as EN 60601-2-17 on 2004-03-01.
This European Standard supersedes EN 60601-2-17:1996 + A1:1996.
The following dates were fixed:
– latest date by which the EN has to be implemented
at national level by publication of an identical
national standard or by endorsement (dop) 2004-12-01
– latest date by which the national standards conflicting
with the EN have to be withdrawn (dow) 2007-03-01
In this standard, the following print types are used:
– requirements, compliance with which can be tested, and definitions: roman type;
– explanations, advice, notes, general statements, exceptions and references: small roman type;
– test specifications: italic type;
– TERMS USED THROUGHOUT THIS PARTICULAR STANDARD WHICH ARE DEFINED IN CLAUSE 2 OR IN THE
GENERAL STANDARD EN 60601-1, ITS COLLATERAL OR PART 2 STANDARDS, OR IN IEC 60788: SMALL
CAPITALS.
Annex ZA has been added by CENELEC.
__________
Endorsement notice
The text of the International Standard IEC 60601-2-17:2004 was approved by CENELEC as a
European Standard without any modification.
In the official version, for Bibliography, the following note has to be added for the standard indicated:
IEC 60601-1-3 NOTE  Harmonized as EN 60601-1-3:1994 (not modified).
__________
- 3 - EN 60601-2-17:2004
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
NOTE Where an international publication has been modified by common modifications, indicated by (mod), the relevant
EN/HD applies.
Publication Year Title EN/HD Year
Addition to Annex ZA of EN 60601-1:1990/A2:1995:
IEC 60788 1984 Medical radiology - Terminology HD 501 S1 1988

IEC 61217 1996 Radiotherapy equipment - Coordinates, EN 61217 1996
movements and scales
A1 2000 A1 2001
IEC 62083 2000 Medical electrical equipment EN 62083 2001
Requirements for the safety of
radiotherapy treatment planning systems
Replacement in Annex ZA of EN 60601-1:1990/A2:1995:
IEC 60601-1 1988 Medical electrical equipment  EN 60601-1 1990
Part 1: General requirements for safety + corr. July 1994
A1 1991  A1 1993
+ corr. July 1994
A2 1995  A2 1995
+ corr. June 1995
A13 1996
IEC 60601-1-1 2000 Medical electrical equipment EN 60601-1-1 2001
Part 1-1: General requirements for safety -
Collateral standard: Safety requirements
for medical electrical systems

IEC 60601-1-2 2001 Medical electrical equipment EN 60601-1-2 2001
Part 1-2: General requirements for safety -
Collateral standard: Electromagnetic
compatibility - Requirements and tests

IEC 60601-1-4 1996 Medical electrical equipment EN 60601-1-4 1996
Part 1-4: General requirements for safety -
Collateral standard: Programmable
electrical medical systems
A1 1999 A1 1999
NORME CEI
INTERNATIONALE
IEC
60601-2-17
INTERNATIONAL
Deuxième édition
STANDARD
Second edition
2004-01
Appareils électromédicaux –
Partie 2-17:
Règles particulières de sécurité des appareils
projecteurs de sources radioactives à chargement
différé automatique utilisés en brachythérapie

Medical electrical equipment –
Part 2-17:
Particular requirements for the safety of
automatically-controlled brachytherapy
afterloading equipment
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МеждународнаяЭлектротехническаяКомиссия
Pour prix, voir catalogue en vigueur
For price, see current catalogue

60601-2-17  IEC:2005 – 3 –
CONTENTS
FOREWORD.5
INTRODUCTION.9

SECTION ONE – GENERAL
1 Scope and object .11
2 Terminology and definitions .15
4 General requirements for tests.21
5 Classification .21
6 Identification, marking and documents .23

SECTION TWO – ENVIRONMENTAL CONDITIONS
10 Environmental conditions .31

SECTION THREE – PROTECTION AGAINST ELECTRIC SHOCK HAZARDS

SECTION FOUR – PROTECTION AGAINST MECHANICAL HAZARDS.

SECTION FIVE – PROTECTION AGAINST HAZARDS
FROM UNWANTED OR EXCESSIVE RADIATION
29 X-radiation.33
30 Alpha, beta, gamma, NEUTRON RADIATION and other particle radiation .33

SECTION SIX – PROTECTION AGAINST HAZARDS OF IGNITION
OF FLAMMABLE ANAESTHETIC MIXTURES

SECTION SEVEN – PROTECTION AGAINST EXCESSIVE TEMPERATURES
AND OTHER SAFETY HAZARDS
SECTION EIGHT – ACCURACY OF OPERATING DATA AND PROTECTION
AGAINST HAZARDOUS OUTPUT
50 Accuracy of operating data.55

SECTION NINE – ABNORMAL OPERATION AND FAULT CONDITIONS;
ENVIRONMENTAL TESTS
52 Abnormal operation and fault conditions.59

SECTION TEN – CONSTRUCTIONAL REQUIREMENTS

Appendix L (normative) References – Publications mentioned in this standard.63

Bibliography .65
Index of defined terms.67

60601-2-17  IEC:2005 – 5 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
___________
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-17: Particular requirements for the safety of
automatically-controlled brachytherapy afterloading equipment

FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested
in the subject dealt with may participate in this preparatory work. International, governmental and non-
governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely
with the International Organization for Standardization (ISO) in accordance with conditions determined by
agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence
between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
the latter.
5) IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with an IEC Publication.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
International Standard IEC 60601-2-17 has been prepared by subcommittee 62C: Equipment
for radiotherapy, nuclear medicine and radiation dosimetry, of IEC technical committee 62:
Electrical equipment in medical practice.
This second edition cancels and replaces the first edition published in 1989, and its
Amendment 1 (1996). Consideration has been given to new IEC standards, amendments to
existing IEC standards, developments in technology and clinical usage, and various hazards
encountered and envisaged since the preparation of the first edition.
This bilingual version (2005-09) replaces the English version.

60601-2-17  IEC:2005 – 7 –
The text of this standard is based on the following documents:
FDIS Report on voting
62C/363/FDIS 62C/366/RVD
Full information on the voting for the approval of this standard can be found in the report on
voting indicated in the above table.
The French version of this standard has not been voted upon.
In this Particular Standard, the following print types are used:
– requirements, compliance with which can be tested, and definitions: roman type;
– explanations, advice, notes, general statements, exceptions and references: small roman type;
– test specifications: italic type;
– TERMS USED THROUGHOUT THIS PARTICULAR STANDARD WHICH ARE DEFINED IN CLAUSE
2 OR IN THE GENERAL STANDARD IEC 60601-1, ITS COLLATERAL OR PART 2 STANDARDS,
OR IN IEC 60788: SMALL CAPITALS.
NOTE Attention is drawn to the existence, in some countries, of legislation containing requirements for:
– IONIZING RADIATION safety which may not align with the provisions of this Particular Standard, and
– maintenance, quality assurance and other related subjects, which are not covered by this Standard.
The committee has decided that the contents of this publication will remain unchanged until the
maintenance result date indicated on the IEC web site under "http://webstore.iec.ch" in the data
related to the specific publication. At this date, the publication will be
• reconfirmed;
• withdrawn;
• replaced by a revised edition, or
• amended.
60601-2-17  IEC:2005 – 9 –
INTRODUCTION
The use of AFTERLOADING EQUIPMENT for BRACHYTHERAPY purposes may expose PATIENTS
to danger if the EQUIPMENT fails to deliver the required dose to the PATIENT, or if the
EQUIPMENT design does not satisfy standards of electrical and mechanical safety. The
EQUIPMENT may also cause danger to persons in the vicinity if the EQUIPMENT itself fails to
contain the RADIOACTIVE SOURCE(S) adequately within the STORAGE CONTAINER(S) and/or if
there are inadequacies in the design of the TREATMENT ROOM.
This Particular Standard establishes requirements to be complied with by MANUFACTURERS in
the design and construction of AFTERLOADING EQUIPMENT for use in temporary BRACHY-
THERAPY procedures; it does not attempt to define their optimum performance requirements.
Its purpose is to identify those features of design that are regarded, at the present time, as
essential for the safe operation of such EQUIPMENT. It places limits on the degradation of
EQUIPMENT performance beyond which it can be presumed that a fault condition exists and
where an INTERLOCK then operates to return the RADIOACTIVE SOURCE(S) to the STORAGE
CONTAINER(S) and afterwards to prevent continued operation of the EQUIPMENT.

60601-2-17  IEC:2005 – 11 –
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-17: Particular requirements for the safety of
automatically-controlled brachytherapy afterloading equipment

SECTION ONE – GENERAL
The clauses and subclauses of this section of the General Standard apply except as follows:
1 Scope and object
This clause of the General Standard applies except as follows:
1.1 Scope
Addition:
1.1.101 This Particular Standard specifies requirements for the safety of automatically-
controlled EQUIPMENT for BRACHYTHERAPY of patients using AFTERLOADING techniques.
1.1.102 This Standard specifies requirements for automatically-controlled AFTERLOADING
EQUIPMENT
– which contains and uses only beta, gamma, and NEUTRON-emitting SEALED RADIOACTIVE
SOURCES,
– which automatically drives the sealed radioactive source(s) from a storage container to a
treatment position inside the source applicator(s) and returns the source(s) to the storage
container,
– which is designed for connection to a PATIENT, and
– with which movements of the RADIOACTIVE SOURCE(S) are carried out automatically by the
EQUIPMENT according to a prescribed programme using a powered mechanism whose
changes are controlled by the CONTROLLING TIMER(S) and TIMING DEVICES that are either
PROGRAMMABLE ELECTRONIC SUB-SYSTEMS (PESS) (computer or microprocessors) or
non-programmable systems.
1.1.103 This Standard specifies requirements for EQUIPMENT intended to be
– used under the supervision of QUALIFIED PERSONS;
– maintained at predetermined intervals;
– subject to regular checks by the user.
This Standard does not specify requirements for SEALED RADIOACTIVE SOURCES used with the
EQUIPMENT. Such requirements are specified in other standards (see 6.8.3).
1.1.104 The requirements of this Standard are based on the assumptions that:
– a TREATMENT PLAN is available that prescribes appropriate values of the TREATMENT
PARAMETERS, and
– the SOURCE STRENGTH(S) of the RADIOACTIVE SOURCE(S) used by the EQUIPMENT is (are)
known.
60601-2-17  IEC:2005 – 13 –
This Standard includes requirements intended to ensure that the prescribed values of the
TREATMENT PARAMETERS can be achieved by the EQUIPMENT, in particular that:
– the selected RADIOACTIVE SOURCE(S) is (are) positioned or moved within the SOURCE
APPLICATOR in the selected configuration relative to the SOURCE APPLICATOR;
– IRRADIATION is performed by the selected RADIOACTIVE SOURCE configuration for the
selected duration;
– IRRADIATION is performed by the EQUIPMENT without causing unnecessary risk to the
OPERATOR or other persons in the immediate surroundings.
1.2 Object
Replacement:
The object of this Particular Standard is to establish particular requirements for safety of
automatically-controlled BRACHYTHERAPY AFTERLOADING EQUIPMENT and the compliance test
specifications. It presents the general functional requirements of the demand for safety rather
than particular technological means of implementation.
1.3 Particular Standards
ADDITION:
1.3.101 Relationship to the General Standard
This Particular Standard is to be read in conjunction with IEC 60601-1:1988, Medical electrical
equipment – Part 1: General requirements for safety, with its Amendments 1 (1991) and 2
(1995) – hereinafter referred to as the General Standard – which it amends and supplements.
As in the General Standard, the requirements are followed by compliance tests.
The numbering of sections, clauses and subclauses of this Particular Standard corresponds to
that of the General Standard. The changes to the text of the General and Collateral Standards
are specified by the use of the following words:
"Replacement" means that the clause or subclause of the General Standard is replaced
completely by the text of this Particular Standard;
"Addition" means that the text of this Particular Standard is additional to the requirements of
the General Standard;
"Amendment" means that the clause or subclause of the General Standard is amended as
indicated by the text of this Particular Standard.
Subclauses, figures or tables which are additional to those of the General Standard are
numbered starting from 101: additional annexes are lettered AA, BB, etc., and additional items
aa), bb), etc.
The term “this Standard “ is used to make reference to the General Standard and this
Particular Standard taken together.
Where there is no corresponding section, clause or subclause in this Particular Standard, the
section, clause or subclause of the General Standard, although possibly not relevant, applies
without modification.
60601-2-17  IEC:2005 – 15 –
Where it is intended that any part of the General Standard, although possibly relevant, is not to
be applied, a statement to that effect is given in this Particular Standard.
The requirements of this Particular Standard take priority over those of the General Standard.
1.3.102 Relationship to other standards and documents
NOTE See Appendix L for normative references.
1.5 Collateral Standards
Addition:
1.5.101 IEC 60601-1-1
All clauses and subclauses of Collateral Standard IEC 60601-1-1apply.
1.5.102 IEC 60601-1-2
All clauses and subclauses of Collateral Standard IEC 60601-1-2 apply.
1.5.103 IEC 60601-1-3
Collateral Standard IEC 60601-1-3 does not apply.
1.5.104 IEC 60601-1-4
All clauses and subclauses of Collateral Standard IEC 60601-1-4 apply.
2 Terminology and definitions
This clause of the General Standard applies except as follows:
Addition:
For the purposes of this document, the terms and definitions given in the General Standard or
in its Collateral Standards and the following apply.
NOTE 1 The Index of defined terms at the end of this document lists defined terms alphabetically with their source
reference.
NOTE 2 In this Particular Standard, IRRADIATION refers to the entire process of exposing the patient to
RADIOACTIVE SOURCES in positions and for periods of time appropriate for TREATMENT. TRANSIT times are explicitly
excluded from the TREATMENT TIME.
NOTE 3 Although the actual titles of the persons fulfilling the following roles may vary from country to country, in
this Particular Standard the term 'OPERATOR' is used to denote the person controlling the BRACHYTHERAPY
EQUIPMENT during treatment, and the term 'USER' to denote the organization or individual responsible for the use
and maintenance of the BRACHYTHERAPY AFTERLOADING EQUIPMENT. The terms 'radiotherapist' and 'radiation
oncologist', although not used in this Particular Standard, are used in many countries to denote the person
exercising medical supervision and responsibility for determining and prescribing PATIENT treatment.

60601-2-17  IEC:2005 – 17 –
2.1 EQUIPMENT parts, auxiliaries and ACCESSORIES
Additional definitions:
2.1.101
ABBREVIATIONS
The following abbreviations are used in this standard:
– PESS programmable electronic sub-system
– SFC single fault condition
– TCP treatment control panel
2.1.102
BETA SOURCE STRENGTH
–1
ABSORBED DOSE RATE [Gy s ] in water at 2 mm along the perpendicular bisector from a
RADIOACTIVE SOURCE emitting beta RADIATION
2.1.103
BRACHYTHERAPY
INTRACAVITARY, INTERSTITIAL, SUPERFICIAL or INTRALUMINAL RADIOTHERAPY using one or
more SEALED RADIOACTIVE SOURCES
2.1.104
CONTINUATION
in , re-starting IRRADIATION after INTERRUPTION of IRRADIATION without re-
selection of OPERATING conditions
2.1.105
DWELL TIME
time a RADIOACTIVE SOURCE or a RADIOACTIVE SOURCE TRAIN remains at a selected
TREATMENT position
2.1.106
GAMMA SOURCE STRENGTH
REFERENCE AIR KERMA RATE of a BRACHYTHERAPY SOURCE emitting gamma rays. The unit
–1
of GAMMA SOURCE STRENGTH is Gy s at 1 m
NOTE Multiples (milli, mega, etc.) are permitted.
2.1.107
INITIATION
in , commencing IRRADIATION from the READY STATE when the READY
STATE was attained by carrying out selection and confirming the operating conditions and not
by INTERRUPTION OF IRRADIATION
2.1.108
INTERRUPTION OF IRRADIATION, TO INTERRUPT RADIATION
stopping IRRADIATION prior to TERMINATION OF IRRADIATION with the possibility of
CONTINUATION without reselection of operating conditions
2.1.109
INTRALUMINAL RADIOTHERAPY
RADIOTHERAPY in which one or more RADIOACTIVE SOURCES, with or without SOURCE
APPLICATORS, are introduced into a body lumen such as a blood vessel, airway, or the
gastrointestinal tract
60601-2-17  IEC:2005 – 19 –
2.1.110
NEUTRON SOURCE STRENGTH
dose rate of a brachytherapy source emitting neutrons. The unit of NEUTRON SOURCE
–1
STRENGTH is Gy s at 1 m
2.1.111
QUALIFIED PERSON
person recognized by a competent authority as having the requisite knowledge and training to
perform particular duties
2.1.112
RADIOACTIVE SOURCE TRAIN
sequence of SEALED RADIOACTIVE SOURCES, possibly separated by non-RADIOACTIVE
spacers, either permanently combined or selected prior to each IRRADIATION, and used in
AFTERLOADING EQUIPMENT. The RADIOACTIVE SOURCE TRAIN is usually selected to give a
specified dose distribution
2.1.113
REFERENCE AIR KERMA RATE
air kerma rate, at a reference distance of 1 m, after correction for air attenuation and scattering
&
NOTE The reference air kerma rate, K , is similar to the air kerma strength, S , used in the USA, which is the
R K
product of air-kerma rate in free space and the square of the distance of the calibration point from the source centre
along the perpendicular bisector.
2.1.114
SOURCE STRENGTH
GAMMA SOURCE STRENGTH, BETA SOURCE STRENGTH, or NEUTRON SOURCE STRENGTH of a
RADIOACTIVE SOURCE, whichever is applicable for the intended use of the EQUIPMENT
2.1.115
TERMINATION OF IRRADIATION
stopping or preventing further IRRADIATION with no possibility of re-starting without the
reselection of operating conditions (i.e., returning to the PREPARATORY STATE)
2.1.116
TRANSIT
the period during which the RADIOACTIVE SOURCES move from the STORAGE CONTAINER(S) to
a treatment position or move from a treatment position to the STORAGE CONTAINER(S)
2.1.117
TREATMENT PARAMETER
factor that describes one aspect of the irradiation of a patient during radiotherapy, such as
radiation energy, absorbed dose, treatment time
2.1.118
TREATMENT TIME
the sum of the DWELL TIMES which constitute a TREATMENT

60601-2-17  IEC:2005 – 21 –
4 General requirements for tests
This clause of the General Standard applies except as follows:
4.1 Tests
Addition:
Appropriate care should be taken to carry out compliance tests safely, for example by using a
non-RADIOACTIVE SOURCE wherever possible. TYPE TESTS described in this Particular
Standard may also be used by the MANUFACTURER or by the installer as routine tests.
5 Classification
Replacement:
EQUIPMENT and its APPLIED PARTS shall be classified and marked/identified as described in
Clause 6. This includes:
5.1 According to the type of protection against electric shock:
– EQUIPMENT within the scope of this standard shall be CLASS 1 EQUIPMENT.
5.2 According to the degree of protection against electric shock:
– APPLIED PART within the scope of this Standard shall be TYPE B APPLIED PART,
unless otherwise specified.
5.3 According to the degree of protection against ingress of water detailed in IEC 60529 –
IPX0, unless otherwise specified.
5.4 According to the method(s) of sterilization or disinfection recommended in the
INSTRUCTIONS FOR USE.
5.5 According to the degree of safety of application in the presence of a FLAMMABLE
ANAESTHETIC MIXTURE WITH AIR or FLAMMABLE ANAESTHETIC MIXTURE WITH OXYGEN
OR NITROUS OXIDE:
– EQUIPMENT within the scope of this Standard shall be EQUIPMENT not suitable for use
in the presence of a FLAMMABLE ANAESTHETIC MIXTURE WITH AIR or FLAMMABLE
ANAESTHETIC MIXTURE WITH OXYGEN OR NITROUS OXIDE or as otherwise specified.
5.6 According to the mode of operation:
– EQUIPMENT within the scope of this Standard shall be suitable for CONTINUOUS
OPERATION.
60601-2-17  IEC:2005 – 23 –
6 Identification, marking and documents
This clause of the General Standard applies except as follows:
6.1 Marking on the outside of EQUIPMENT or EQUIPMENT parts
z) Removable protective means
Replacement:
EQUIPMENT shall be declared as unsuitable for alternative applications that require the removal
of a protective means to utilise a particular function.
Compliance is checked by inspection of the ACCOMPANYING DOCUMENTS.
Additional items:
aa) The EQUIPMENT shall be provided with permanently affixed and clearly legible markings on
the appropriate part showing:
1) the maximum total SOURCE STRENGTHS of each of the RADIONUCLIDES for which the
EQUIPMENT is designed;
2) the symbol ISO 361 indicating possible radiation hazard;
3) the requirement for the STORAGE CONTAINER(s) to be located only in a treatment room
with restricted access, if this is specified (see 30.1.1);
4) additional external supply requirements (e.g. compressed air), if any.
bb) For EQUIPMENT with more than one RADIOACTIVE SOURCE, the EQUIPMENT shall be
provided with a permanently affixed means (e.g. a PESS) by which either the USER or the
MANUFACTURER can indicate the RADIOACTIVE SOURCES and their configurations that can
be selected for each CHANNEL.
cc) The EQUIPMENT shall be provided with a permanently affixed means by which either the
USER or the MANUFACTURER can indicate the RADIONUCLIDE(S) that are being kept in the
STORAGE CONTAINER(S) and its/their SOURCE STRENGTH(S) on given date(s).
dd) Each interchangeable SOURCE APPLICATOR shall be permanently marked, or where
appropriate, marked on the packaging, with specific identification.
ee) Each rigid SOURCE APPLICATOR with a clinically significant asymmetrical feature (e.g.
curved or partially shielded) and capable of insertion into a PATIENT in different orientations
shall be so marked that its orientation can be identified after insertion unless the
ACCOMPANYING DOCUMENTS contain a recommendation that radiographic or other
appropriate checks be carried out.
NOTE The identification of BRACHYTHERAPY SOURCE activity (e.g. in curies or becquerels) is required by some
regulatory agencies.
60601-2-17  IEC:2005 – 25 –
6.7 Indicator lights and push-buttons
A) COLOURS OF INDICATOR LIGHTS
Replacement:
Where indicator lights are used on the TREATMENT CONTROL PANEL, or on other control
panels, the colours of the lights shall accord with the following:
– Immediate action required in response to an unintended state of operation Red
– RADIOACTIVE SOURCE(S) at the treatment position(s) Yellow
– RADIOACTIVE SOURCE(S) in TRANSIT Yellow (flashing)
– READY STATE Green
– EQUIPMENT switched on but all the operations required to reach the READY STATE not White
yet carried out
The status of the EQUIPMENT shall be indicated also by means other than the colour; e.g., by
the shape or location of the indicator, or by accompanying text.
For AFTERLOADERS other than those intended to be operated in the vicinity of the patient,
indicator lights in the TREATMENT ROOM but not on the TREATMENT CONTROL PANEL to
indicate that the RADIOACTIVE SOURCE(S) is (are) either at the treatment position(s) or in
TRANSIT should be coloured red. This colour is required because any USER in the TREATMENT
ROOM observing a red light should take immediate action.
6.8 ACCOMPANYING DOCUMENTS
6.8.2 INSTRUCTIONS FOR USE
d) Cleaning, disinfection and sterilisation of parts in contact with the PATIENT
Addition:
INSTRUCTIONS FOR USE shall also include a warning of the risk that may arise during wet or
steam sterilisation whereby liquids may become trapped in cavities and subsequently
transferred to other parts of the system. This warning shall include the risk of corrosive
damage to the SEALED RADIOACTIVE SOURCE(S) and the SOURCE DRIVE MECHANISM(S) in the
event that trapped liquids are present.
e) MAINS operated EQUIPMENT with additional power source
Replacement:
INSTRUCTIONS FOR USE shall include instructions for carrying out and recommendations on
the frequency of all periodic checking, maintenance and recharging of batteries and of any
other additional internal power source(s).
Additional items:
aa) Checking INTERLOCKS
INSTRUCTIONS FOR USE shall contain instructions for carrying out and recommendations on
the frequency of checks on all INTERLOCKS.

60601-2-17  IEC:2005 – 27 –
bb) Checking the security of couplings and connections
INSTRUCTIONS FOR USE shall contain instructions for the procedures to be carried out to check
the security of the connection, if any, of RADIOACTIVE SOURCE(S) to SOURCE DRIVE
MECHANISM(S), and of the couplings of CHANNEL(S) to SOURCE APPLICATOR(S).
cc) Need for special procedures after a failure of a CONTROLLING TIMER
INSTRUCTIONS FOR USE shall contain an explanation of the need for special procedures after a
failure of a CONTROLLING TIMER (see 30.3.2 c) of this Particular Standard).
dd) Failure of RADIOACTIVE SOURCE to return to the STORAGE CONTAINER
INSTRUCTIONS FOR USE shall contain advice on the recommended procedures to be adopted
in the case of failure of a RADIOACTIVE SOURCE to return to the STORAGE CONTAINER and on
any emergency EQUIPMENT that may be required.
ee) TRANSIT ABSORBED DOSE
INSTRUCTIONS FOR USE shall contain information on AIR KERMA (or ABSORBED DOSE) at the
positions specified in 50.1.4 of this Particular Standard by the TRANSIT from the STORAGE
CONTAINER to the TREATMENT position and the return of a specified RADIOACTIVE SOURCE.
INSTRUCTIONS FOR USE shall advise that the expected total TRANSIT dose should be
determined and, if necessary, allowed for in dose calculations.
INSTRUCTIONS FOR USE shall also contain a warning that the accurate achievement of the
prescribed dose may be compromised if many TRANSITS of the RADIOACTIVE SOURCE(S) from
and return to the STORAGE CONTAINER are carried out during the treatment.
ff) Limitations of CHANNELS and SOURCE APPLICATOR(S)
INSTRUCTIONS FOR USE shall state:
– the minimum radii of curvature for a specified inside diameter of CHANNEL(S) and SOURCE
APPLICATORS which are allowable for normal operation;
– the conditions of the positional arrangements of CHANNEL(S) and SOURCE APPLICATOR(S)
under which the agreement required by 50.2.1 of this Particular Standard does not hold,
with an explanation of the relation to the clinical purposes for which the EQUIPMENT is
specified (see 1.1.104 of this Particular Standard);
– the nature of any obstacles of CHANNEL(S) and SOURCE APPLICATOR(S) that might impede
the free passage of RADIOACTIVE SOURCE(S) or RADIOACTIVE SOURCE TRAIN(S).
gg) Check for contamination
INSTRUCTIONS FOR USE shall contain recommendations regarding appropriate checks for
leakage of RADIOACTIVITY from the RADIOACTIVE SOURCE(S).
hh) Asymmetric SOURCE APPLICATOR check
Where appropriate (see 6.1) INSTRUCTIONS FOR USE shall contain a recommendation that
radiographic or other checks be carried out on the orientation of asymmetric SOURCE
APPLICATOR(S).
60601-2-17  IEC:2005 – 29 –
ii) Functional checks and maintenance
INSTRUCTIONS FOR USE shall contain recommendations to the USER on the regular functional
checks to be performed and the required maintenance of the EQUIPMENT that should ensure
continued safe use, particularly on the maintenance of the SOURCE DRIVE MECHANISM.
INSTRUCTIONS FOR USE shall, where appropriate, include recommendations to carry out tests
using non-RADIOACTIVE SOURCES.
jj) Limitations on source transitions
The INSTRUCTIONS FOR USE shall contain the maximum number of transitions of the
RADIOACTIVE SOURCE(S) from the STORAGE CONTAINER to the SOURCE APPLICATOR and
back to the STORAGE CONTAINER. If no limit on number of transitions is imposed, the
INSTRUCTIONS FOR USE shall state this.
kk) Checking the source strength(s) of the radioactive source(s)
INSTRUCTIONS FOR USE shall contain a recommendation that a measurement be made from
which the SOURCE STRENGTH of each newly received RADIOACTIVE SOURCE can be
determined with sufficient accuracy and compared with any values used internally by the
EQUIPMENT.
6.8.3 Technical description
a) General
Addition:
The technical description shall state:
1) whether the EQUIPMENT is specified and intended for use only with the STORAGE
CONTAINER(S) in a TREATMENT ROOM with restricted access (see 30.1.1);
2) the RADIONUCLIDE(S), the corresponding maximum SOURCE STRENGTH(S) of the
RADIOACTIVE SOURCE(S) for which the EQUIPMENT is designed and the corresponding
LEAKAGE RADIATION from the STORAGE CONTAINER;
3) the range of permissible configurations for the RADIOACTIVE SOURCE TRAIN(S), if any;
RADIOACTIVE SOURCES from other suppliers, in which
4) whether it is permissible to have
case dimensions and tolerances of the CAPSULES for THE RADIOACTIVE SOURCES shall
be stated;
5) the international standards whose requirements the RADIOACTIVE SOURCES should
meet, together with any other specific requirements;
6) whether it is permissible to have SOURCE APPLICATORS from other suppliers, in which
case relevant dimensions and tolerances shall be stated, and a recommendation given
that such SOURCE APPLICATORS should be tested for compliance with requirements on
position and security of couplings;
7) the tolerances for:
– RADIOACTIVE SOURCE positioning during treatment ;
– transit time;
– dwell time.
60601-2-17  IEC:2005 – 31 –
The technical description shall further state:
8) that the requirements in this Particular Standard cannot guarantee that the presence of
a RADIOACTIVE SOURCE outside the STORAGE CONTAINER will be indicated under all
fault conditions;
9) that the use of an independent radiation monitor appropriate for the radiation type in the
vicinity of the PATIENT is recommended;
10) that if provided, an independent radiation monitor adjacent to any part of the
EQUIPMENT should be capable of giving a visible indication of RADIATION and should
function properly at the maximum radiation levels that might be expected in the vicinity
of the EQUIPMENT;
11) that the radiation monitor should continue to function and give the indication for several
hours after a power failure (e.g. battery back-up).
The technical description shall contain details for the connection of the suitable device(s) that
can ensure an INTERRUPTION (see 30.1.8).
The technical description shall provide guidance and precautions regarding the identification,
handling and disposal of equipment or equipment parts that may exhibit RADIOACTIVITY.
The technical description shall include one or more dose distributions that are representative of
the clinical use of the device. The dose distribution(s) shall include the influence of the
SOURCE APPLICATOR.
SECTION TWO – ENVIRONMENTAL CONDITIONS
10 Environmental conditions
This clause of the General Standard applies except as follows:
10.2.1 Environment
Replacement:
a) Ambient temperature between +15˚C and +35 ˚C.
b) Relative humidity between 30 % and 75 %.
c) Atmospheric pressure between 70 kPa and 110 kPa.
d) Unless otherwise specified by the MANUFACTURER.

SECTION THREE – PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
The clauses and subclauses of this section of the General Standard apply.

SECTION FOUR – PROTECTION AGAINST MECHANICAL HAZARDS.
The clauses and subclauses of this section of the General Standard apply.

60601-2-17  IEC:2005 – 33 –
SECTION FIVE – PROTECTION AGAINST HAZARDS
FROM UNWANTED OR EXCESSIVE RADIATION
The clauses and subclauses of this section of the General Standard apply except as follows.
29 X-radiation
Not used.
30 Alpha, beta, gamma, NEUTRON RADIATION and other particle radiation
This clause of the General Standard applies except as follows:
Replacement:
The main requirements of this clause are grouped. The first group of subclauses applies to
NORMAL USE and NORMAL CONDITION and its objective is the safe and satisfactory
achievement of the prescribed TREATMENT PARAMETERS. The second group is designed to
give protection against other than NORMAL USE. The last group of subclauses applies to
SINGLE FAULT CONDITIONS and its objective is to protect the PATIENT and the OPERATORS
from hazard.
30.1 Protection in NORMAL USE and NORMAL CONDITION
The requirements of this subclause cover the shielded storage of the RADIOACTIVE SOURCES,
the indications of their positions, the timing and selection of modes of treatment, and the
control of movements. They do not cover the temporary storage of sources under emergency
conditions or the transport of the EQUIPMENT from one area with restricted access to another.
30.1.1 Limitation of LEAKAGE RADIATION from the STORAGE CONTAINER(S)
These requirements a) and b) shall be met for each specified STORAGE CONTAINER with all
combinations of RADIOACTIVE SOURCES specified in the ACCOMPANYING DOCUMENTS as
suitable to be contained within the STORAGE CONTAINER.
a) General use of the STORAGE CONTAINER(S)
This requirement shall be met except where the STORAGE CONTAINER(S) are specified in
the ACCOMPANYING DOCUMENTS as being suitable for installation and use only in a
TREATMENT ROOM with restricted access.
The DOSE EQUIVALENT RATE at any position 50 mm from the surface of the STORAGE
–1
CONTAINER or any other surface permanently fixed to it shall not exceed 0,01 mSv h .
The DOSE EQUIVALENT RATE at any position 1 m from the surface of the STORAGE
–1
CONTAINER or any other surface permanently fixed to it shall not exceed 0,001 mSv h .
Compliance is checked by the following tests:
DOSE EQUIVALENT RATE shall be averaged over an
– for measurements at 50 mm the
area up to but not exceeding 10 cm ;
– for measurements at 1 m the DOSE EQUIVALENT RATE shall be averaged over an area
up to but not exceeding 100 cm ;

60601-2-17  IEC:2005 – 35 –
– measurements shall be made with the combination of RADIOACTIVE SOURCES that is
possible within the specifications given by the MANUFACTURERS and is the least
favourable with regard to this requirement.
b) STORAGE CONTAINER(S) specified for use in a TREATMENT ROOM with restricted access
This requirement shall be met where the STORAGE CONTAINER(S) are stated in the
ACCOMPANYING DOCUMENTS as being suitable for installation and use only in the
TREATMENT ROOM with restricted access.
The DOSE EQUIVALENT RATE at a
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